Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01359852 | A Study of [11C]JNJ-42491293, a Possible PET Ligand for the mGlu2 Receptor, in Healthy Adult Volunteers | PHASE1 | COMPLETED | 20 | — | — | Dec 1, 2010 | Jul 1, 2011 | Jul 22, 2011 | - | — |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | \[11C\] JNJ-42491293 + JNJ-40411813 Part C:\[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v.bolus injection. Volunteers will be pre-treated with JNJ-40411813 between 1.5 to 3 hours prior to the second and prior to the third PET scan,\[11C\] JNJ-42491293 + JNJ-40411813 Part D:\[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection. Volunteers will be treated with a single dose of up to 500 mg JNJ-40411813 prior to the second scan and will have a third scan at least 2 hours later to evaluate the rate of clearance of JNJ-40411813 from the brain,\[11C\] JNJ-42491293 Part A: \[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection and have a 120 minute PET scan.,\[11C\] JNJ-42491293 Part B:\[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection have a 90 minute PET scan and have arterial and venous blood sampling. |
| Name | Type | Description |
|---|---|---|
| [11C] JNJ-42491293 | DRUG | Part B:\[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection, have a 90 minute PET scan and have arterial and venous blood sampling. |
| [11C] JNJ-42491293 + JNJ-40411813 | DRUG | Part C:\[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v.bolus injection. Volunteers will be pre-treated with JNJ-40411813 between 1.5 to 3 hours prior to the second and prior to the third PET scan |
Inclusion Criteria: * Body mass index (BMI) between 18 and 30 kg/m2, inclusive (BMI = weight/height2) * Nonsmokers (at least 3 months before screening) * Healthy on the basis of results from physical examination, vital signs, and 12-lead ECG, clinical laboratory tests performed at screening as dete...